Moderna completes enrollment for phase 2 coronavirus vaccine trial
Protocol for the phase 3 study has already been finalized, following feedback Moderna received from the US Food and Drug Administration.
By JERUSALEM POST STAFFA sign marks the headquarters of Moderna Therapeutics, which is developing a vaccine against the coronavirus disease (COVID-19), in Cambridge, Massachusetts, U.S., May 18, 2020(photo credit: REUTERS/BRIAN SNYDER)Moderna has finished enrollment for its phase 2 study of its coronavirus vaccine.The vaccine candidate, which is called mRNA-1273, is its second mRNA vaccine to complete enrollment of a phase 2 study. Enroled in this study are healthy younger adults aged 18-55 and older adults aged 55 years and above.This Phase 2 placebo-controlled, dose-confirmation study is evaluating the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart.In addition, Moderna also successfully completed enrollment of older adults aged 56-70 and elderly adults aged 71 and above in an NIH-led phase 1 study. “I would like to thank the healthy volunteer participants, our partners at clinical trial sites and the dedicated Moderna team for their support in completing enrollment of the phase 2 study of mRNA-1273, our vaccine candidate against COVID-19,” Moderna chief medical officer Tal Zaks, M.D., Ph.D. said in a statement. “We are committed to helping address this ongoing public health emergency and continue to focus on our phase 3 study, which remains on track to start in July, less than seven months from the sequencing of the virus.”Protocol for the phase 3 study has already been finalized, following feedback Moderna received from the US Food and Drug Administration.
